COMPACT ABSORBER 427002100 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-08-31 for COMPACT ABSORBER 427002100 * manufactured by Ge Healthcare Finland Oy.

Event Text Entries

[533256] Customer reportedly noted a build up of pressure in the machine. There was no reported pt injury. Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5


[7914302] Ge healthcare plans to undertake a field correction to address this condition.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610105-2006-00017
MDR Report Key778968
Report Source05
Date Received2006-08-31
Date of Report2006-08-31
Date of Event2006-08-09
Date Mfgr Received2006-08-09
Device Manufacturer Date2006-06-01
Date Added to Maude2006-11-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactANN LEBAR
Manufacturer Street9900 INNOVATION DR MAIL STOP: RP2138
Manufacturer CityWAUWATOSA WI 53226
Manufacturer CountryUS
Manufacturer Postal53226
Manufacturer Phone4147213947
Manufacturer G1GE HEALTHCARE FINLAND OY
Manufacturer Street*
Manufacturer City*
Manufacturer CountryFI
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMPACT ABSORBER
Generic NameCARBON DIOXIDE ABSORBER
Product CodeBSF
Date Received2006-08-31
Model Number427002100
Catalog Number*
Lot Number023066
ID NumberSAMPLE #2
Device Expiration Date2008-06-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key766743
ManufacturerGE HEALTHCARE FINLAND OY
Manufacturer AddressKUORTANEENKATU 2 HELSINKI FI FIN-00510
Baseline Brand NameDATEX-OHMEDA COMPACT ABSORBER, DISPOSABLE
Baseline Generic NameABSORBER
Baseline Model No427002100
Baseline Catalog No427002100
Baseline IDNA
Baseline Device FamilyNA
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
10 2006-08-31

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